Dental restoration molds

ABSTRACT

A custom tool for forming a dental restoration in a mouth of a patient includes a facial mold body for a patient-specific, customized fit with the facial side of at least one tooth of the patient, wherein the facial mold body includes a restorative portion and a first engagement portion extending away from the restorative portion; a lingual mold body for a patient-specific, customized fit with the lingual side of the tooth of the patient, wherein the lingual mold body includes a restorative portion and a first engagement portion extending away from the restorative portion; wherein the first engagement portion of the facial mold body interlocks with the first engagement portion of the lingual mold body; and wherein the facial mold body and lingual mold body are configured to combine with the tooth of the patient to form a mold cavity encompassing missing tooth structure of at least one tooth to be restored.

BACKGROUND

A dental restoration, or a dental filling, utilizes a restorative dentalmaterial to improve function, integrity and morphology of missing orirregular tooth structure. For example, a dental restoration may be usedto restore missing tooth structure due to congenital discrepancies,following external trauma, as part of a restorative treatment for dentalcaries or tooth decay. or for aesthetic reasons.

Restorative dentistry often includes drilling decay from an infectedtooth (commonly referred to as “preparing” the tooth) and then usingsimple tools and a high level of craftsmanship to isolate, retract, filland contour the finished restoration. Quality isolation via a rubber damis cumbersome and often skipped for less effective isolation via cottonrolls—increasing the risk of contamination which reduces longevity ofthe restoration. Retraction of soft and hard tissue includesmanipulation of cords, wedges and matrix bands, and imperfect techniquemay result in contamination, difficulty in finishing and/or polishing ininterproximal areas, and poorly adapted contacts.

While ‘bulk fill’ restorative materials and high intensity curing lightsfacilitate relatively fast filling of deep cavities (e.g., 4-5 mm), manyrestorations are completed in a single shade as practitioners may beuncertain of the correct layering protocol for multiple shades or typesof restorative material. Last, with little geometrical guidanceavailable on a prepared tooth, creation of the final filling level andocclusal surface geometry may include overfilling with restorativedental material, followed by an iterative process of grinding andchecking tooth contact and biting function on an anesthetized patient.This process may be the most time consuming for dental restorations anderrors here may result in tooth sensitivity and return visits foradjustment.

Commonly-assigned patent applications United States Patent Publ. No.2018/0021113, titled “Dental Restoration Molding Techniques,” filed Dec.7, 2015, U.S. patent application Ser. No. 16/061362, titled “One-PieceDental Restoration Molds,” filed Dec. 15, 2016, U.S. patent applicationSer. No. 16/061350, titled “Dental Restoration Molds,” filed Dec. 15,2016, WO 2018/022616 Publ. No., titled “Dental Restoration Molds,” filedJul. 25, 2017, and U.S. Patent Provisional Application Ser. No.62/560457, titled “Dental Restoration Molds,” filed Sep. 19, 2017 alldisclose dental restoration techniques incorporating the molding ofdental restorative material directly on a tooth located within the mouthof a patient.

SUMMARY

This disclosure relates to methods for dental restoration, custom toolsused for dental restoration and techniques for producing custom toolsfor dental restoration In one example, the disclosure is directed to acustom tool for forming a dental restoration in a mouth of a patient.The custom tool comprises: a facial mold body for a patient-specific,customized fit with the facial side of at least one tooth of thepatient, wherein the facial mold body includes a restorative portion anda first engagement portion extending away from the restorative portion;a lingual mold body for a patient-specific, customized fit with thelingual side of the tooth of the patient, wherein the lingual mold bodyincludes a restorative portion and a first engagement portion extendingaway from the restorative portion; wherein the first engagement portionof the facial mold body interlocks with the first engagement portion ofthe lingual mold body; and wherein the facial mold body and lingual moldbody are configured to combine with the tooth of the patient to form amold cavity encompassing missing tooth structure of at least one toothto be restored.

In another example, the custom tool comprises: a facial mold body for apatient-specific, customized fit with the facial side of at least onetooth of the patient, wherein the facial mold body includes arestorative portion a first engagement portion extending away from therestorative portion and generally perpendicular to the occlusal plane,and a second engagement portion extending away from the restorativeportion and generally perpendicular to the occlusal plane; a lingualmold body for a patient-specific, customized fit with the lingual sideof the tooth of the patient, wherein the lingual mold body includes arestorative portion, a first engagement portion extending away from therestorative portion, and a second engagement portion extending away fromthe restorative portion; a first mesial alignment member on the facialmold body and a second mesial alignment member on the lingual mold body;wherein the first engagement portion of the facial mold body interlockswith the first engagement portion of the lingual mold body and whereinthe second engagement portion of the lingual mold body interlocks withthe second engagement portion of the lingual mold body; wherein thefirst mesial alignment member interlocks with the second mesialalignment member; and wherein the facial mold body and lingual mold bodyare configured to combine with the tooth of the patient to form a moldcavity encompassing missing tooth structure of at least one tooth to berestored.

In another example, a custom tool used for dental treatment comprises: afacial body for a patient-specific, customized fit with the facial sideof at least one tooth of the patient, wherein the facial mold bodyincludes a tooth contacting portion and a first engagement portionextending away from the tooth contacting portion; a lingual mold bodyfor a patient-specific, customized fit with the lingual side of thetooth of the patient, wherein the lingual mold body includes a toothcontacting portion and a first engagement portion extending away fromthe tooth contacting portion; wherein the first engagement portion ofthe facial mold body interlocks with the first engagement portion of thelingual mold body; and wherein the interlock portions are configured toprovide a clamping force between the facial body and lingual body.

In yet a further example, this disclosure is directed to another customtool used for dental treatment. This custom tool comprises: a facialbody for a patient-specific, customized fit with the facial side of atleast one tooth of the patient, wherein the facial mold body includes atooth contacting portion and a first engagement portion extending awayfrom the tooth contacting portion; a lingual mold body for apatient-specific, customized fit with the lingual side of the tooth ofthe patient, wherein the lingual mold body includes a tooth contactingportion and a first engagement portion extending away from the toothcontacting portion; wherein the first engagement portion of the facialmold body interlocks with the first engagement portion of the lingualmold body; and wherein there is a designed interference between facialand lingual molds such that a residual seating pressure exists when theengagement portions are interlocked.

In further examples, this disclosure is directed to methods of forming adental restoration, and methods of designing a custom tool for forming adental restoration of a tooth.

The custom tools and methods described herein may be used in combinationwith any of the previously described examples to create full, partial,or sequential restorations in the mouth of a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of an embodiment of a facial mold body that maybe a part of a custom tool for forming a dental restoration;

FIG. 2 is a back view of the facial mold body of FIG. 1;

FIG. 3 is bottom view of the facial mold body of FIG. 1;

FIG. 4 is a front view of an embodiment of a lingual mold body that maybe a part of a custom tool for forming a dental restoration;

FIG. 5 is a back view of the lingual mold body of FIG. 4;

FIG. 6 is a bottom view of the lingual mold body of FIG. 4;

FIG. 7 is a perspective view of the facial mold body of FIG. 1 and thelingual mold body of FIG. 4 prior to interlocking them together;

FIGS. 8a and 8b are bottom views convenient for showing how the facialmold body of FIG. 1 and the lingual mold body of FIG. 4 may interlocktogether to form an embodiment of custom tool for forming a dentalrestoration;

FIG. 9 is a perspective view of the custom tool of FIG. 8b ;

FIG. 10 is a bottom view of the custom tool of FIG. 9 in the mouth of adental patient;

FIGS. 11a-11d illustrate example steps for using the tool of FIG. 9 toform a dental restoration in the mouth of the dental patient;

FIG. 12 illustrates a front view of another embodiment of a facial moldbody that may be a part of a custom tool for forming a dentalrestoration;

FIG. 13 is a back view of the facial mold body of FIG. 12;

FIG. 14 is a top view of the facial mold body of FIG. 12, and anembodiment of a lingual mold body that may be a part of a custom toolfor forming a dental restoration;

FIG. 15 illustrates a front view of another embodiment of a facial moldbody that may be a part of a custom tool for forming a dentalrestoration;

FIG. 16 is a back view of the facial mold body of FIG. 15;

FIG. 17 is bottom view of the facial mold body of FIG. 15, and anembodiment of a lingual mold body to form a custom tool for forming adental restoration;

FIGS. 18a-18c are bottom views of more embodiments of a custom tool forforming a dental restoration, illustrating partial to full dental archembodiments in a patient's mouth; and

FIG. 19 is a perspective view of an embodiment of a custom tool forforming a dental restoration including injection ports.

The following embodiments are intended to be illustrative of the presentdisclosure and not limiting.

DETAILED DESCRIPTION

Restorative dentistry may be used to add tooth structure to a patient'sdentition, e.g., to an existing tooth, in order to improve at least oneof function, integrity, aesthetics, or morphology of missing orirregular tooth structure. For example, restorative dentistry can be anaesthetic treatment to improve appearance of teeth by, for example,altering their shape and/or optical properties (e.g., shade,translucency), which can be achieved using any suitable technique, suchas by applying a veneer, managing position or contour of adjacent softtissues, lessening or removing a gap (diastema) and/or resolving theappearance of malposition. As another example, restorative dentistry maybe used to adjust the biting or chewing function of teeth to affecttooth function and/or other aspects of overall oral health such astemporomandibular joint (TMJ) disorders, excessive wear, periodontalinvolvement, gingival recession or as part of a larger plan to constructa healthy and stable oral environment.

In some cases, a dental restoration process includes drilling decay froman infected tooth or reshaping teeth by removing undesired toothstructure (e.g., which may be referred to as “preparing” the tooth) andthen using tools and craftsmanship to manually isolate, retract, filland contour the finished restoration.

Different techniques may be used to isolate the dental restoration site.Quality isolation of the dental restoration site via a rubber dam can becumbersome and may be skipped for less effective isolation via cottonrolls, which may increase the risk of contamination, reduce longevity ofthe restoration, or both. Retraction of soft and hard tissue may includemanipulation of cords, wedges and matrix bands. Imperfect retractiontechniques may result in contamination, difficulty in achieving propertooth contours and symmetry, finishing and/or polishing in interproximalareas, poorly adapted contacts, or any combination thereof.

While “bulk fill” restorative materials and high intensity curing lightsmay facilitate relatively fast filling of deep cavities (e.g., 4-5 mm),many restorations may be completed in a single shade as practitionersmay be uncertain of the correct layering protocol for multiple shades ortypes of restorative material. Additionally, with little geometricalguidance available on a prepared tooth, creation of the final fillinglevel and occlusal surface geometry may include overfilling withrestorative dental material, followed by an iterative process ofgrinding and checking tooth contact and biting function on ananesthetized patient. This process may be the most time consuming fordental restorations and errors here may result in tooth sensitivity andreturn visits for adjustment.

The tools described herein may include features designed to provideinterferences between the two primary mold portions of the tool andcertain engagement portions which interlock, which overall helps withpreventing relative movement between the mold portions in multipledirections, helps with better clamping of the tool to the patient'steeth and for sealing the two mold portions together. Such interferencesare digitally designed into the custom mold is when it is designed andproduced. Traditional molds do not have digitally designedinterferences. In order to interlock together or separate the two moldportions from each other, they may need to deform or bend. In addition,the tools described herein may eliminate the need for external tools,like ring clamps, and are instead self-contained and thus, quicker andsimpler to install on a patient's teeth. In addition, captive doorsprovide a reduction of individual parts that need to be assembled, anddecreasing the likelihood of losing individual parts. Lastly, the toolsdescribed herein may reduce flash and/or to allow increased control ofthe placement of restorative material compared to practitioners usingmore traditional skills, tools and techniques.

In some examples, a tool described herein may be digitally designed. Forexample, a tool may be designed using a three-dimensional (3D) model ofthe patient's tooth structure (e.g., obtained from an intraoral scan ofall or part of the patient's dentition or scanning of a conventionalimpression or model). The tool can be, for example, manufactured fromthe digital data using an additive technique, such as 3D printing, or asubtractive technique, such as CAD/CAM milling.

In some examples, the tool for a dental restoration may include a molddesigned based on the 3D model of the patient's tooth structure, and mayinclude additional features to provide advantages over molds that areformed based simply on the 3D scan, a wax-up model, or other molds basedsimply on the shape of the anatomy and/or desired tooth structure of thepatient. The disclosed techniques may facilitate high quality dentalrestorations with improved quality, reduced flash, reduced time and/orskill requirements compared to conventional dental restorationtechniques.

Example tools for a dental restoration are described incommonly-assigned patent applications United States Patent Publ. No.2018/0021113, titled “Dental Restoration Molding Techniques,” filed Dec.7, 2015, U.S. patent application Ser. No. 16/061362, titled “One-PieceDental Restoration Molds,” filed Dec. 15, 2016, U.S. patent applicationSer. No. 16/061350, titled “Dental Restoration Molds,” filed Dec. 15,2016, WO 2018/022616 Publ. No., titled “Dental Restoration Molds,” filedJul. 25, 2017, and U.S. Patent Provisional Application Ser. No.62/560457, titled “Dental Restoration Molds,” filed Sep. 19, 2017, theentire contents of which are incorporated by reference.

FIGS. 1, 2, and 3 illustrate an embodiment of a facial portion of thecustom tool 10 of the present invention. FIGS. 4, 5, and 6 illustrate anembodiment of a lingual portion of the custom tool 10 of the presentinvention. “Facial” as used herein, including the claims, refers to thedirection directed toward the cheeks or lips (i.e., the buccal andlabial) of the patient, and opposite the lingual direction. “Lingual” asused herein, including the claims, refers to the direction directedtoward the tongue of the patient, and opposite the facial direction.FIGS. 7, 8 a, 8 b, and 9 illustrate how the facial and lingual portionsfit together to form a complete a custom tool 10 for forming apatient-specific dental restoration.

FIGS. 1-3 are views of the facial mold body 12 custom tool 10 forforming a patient-specific dental restoration. The tool 10 includes afacial mold body 12, which may be configured to provide a customized fitwith at least one tooth of a patient. For example, facial mold body 12may be specifically designed to fit next to, mate with, and providerestorative structure to the at least one tooth. In the example shown inFIG. 1, the facial mold body 12 includes a restorative portion 16 and anengagement portion 18. A practitioner uses the restorative portion 16 ofthe custom tool to restore at least one tooth in the mouth of thepatient. In the illustrated embodiment, there are two engagementportions 18 a, 18 b positioned at opposite ends of the restorativeportion 16, which is located between the engagement portions 18 a, 18 b.This is ideal, but necessary. For example, the facial mold body 12 couldinclude just one engagement portion 18 positioned adjacent therestorative portion 16. In tools having two engagement portions 18 a, 18b, this provides two points of interlock between the lingual and facialmold bodies 12, 14.

The first engagement portion 18 a and second engagement portion 18 bboth extend away from the restorative portion. In the illustratedembodiment, the engagement portions 18 extend at a generally right anglerelative to the restorative portion 16. When compared to the patient'smouth, which includes an occlusal plane shown generally by line A-A (inFIG. 2) the engagement portions 18 extend generally perpendicular tosuch occlusal plane.

The length of the engagement portions 18 extend some distance from therestorative portion 16 of the facial mold body 12. The length of theengagement portions may be customized and optimized for the individualpatient. If the engagement portions are too long, they will stretch thepatient's jaw, making it uncomfortable or painful for the patient. Ifthe engagement portions are too short, the facial mold body 12 willdisengage from the patient's teeth. In one embodiment, the length of theengagement portions may be 1 mm to 5 cm in length. However, it maydepend on where exactly the engagement portions are located in thepatient's mouth. They may be longer, if they are attach to the patient'steeth near the front of the mouth, such as the incisors. They may beshorter, if they are attached to the back of the mouth, like the molars.Also, the patient's overall opening distance between the upper and lowerarches of teeth is a consideration.

As illustrated in FIG. 3, engagement portions 18 of the facial mold body12 may include a variety of engagement surfaces configured to mateappropriately with the engagement surfaces on a lingual mold body 14.Engagement portions 18 a, 18 b of the facial mold body 12 may include aprotrusion 20 a, 20 b respectively or some other mechanism known in theart for interlocking with the lingual mold body 14. In the illustratedembodiment, protrusion 20 includes a first engagement surface 24, asecond engagement surface 26, and a third engagement surface 28.Protrusions 20 a, 20 b are sized and shaped to interlock or snap fitwith the indentations 30 a, 30 b in the lingual mold body 14.Alternatively, engagement portions 18 of the facial mold body 12 couldinclude a protrusion on one end and an indentation on the opposite end,and the lingual mold body 14 could include an indentation on one end anda protrusion on the opposite end, to allow the two bodies 12, 14 tointerlock together. Various structures known in the art may besubstituted for the protrusion 20 and indentations 30, so long as theyassist in securely interlocking the facial mold body 12 to the lingualmold body 14. For example, dovetail vertical slides or button and snapsmay also be used as interlocking features of the engagement portions.

The engagement portions 18 a, 18 b of the facial mold body 12 arestructured to engage with or interlock with the engagement portions 31,32, and 33 on the lingual mold body 14, as explained in more detailbelow in reference to FIGS. 7, 8, and 9.

In the illustrated embodiment, the restorative mold body 16 is sized andshaped to mate with the anterior teeth of a patient. The engagementportions 18 are sized and shaped be adjacent to the posterior teeth.However, in other embodiments (not illustrated), an engagement portion18 could be adjacent the anterior teeth and the restorative portions 16could be adjacent the posterior teeth.

In the example shown in FIG. 1, the facial body 12 includes one or moreapertures 34, which may each be configured to align with a portion of afacial surface of a respective tooth of the patient to be restored. Insome examples, the portion is a majority of the facial surface of thetooth to be restored. For example, aperture 34 a may be configured toalign with a portion comprising a majority of a facial surface of onetooth and aperture 34 b may be configured to align with a portioncomprising a majority of a facial surface of another tooth. The surfaceof the tooth to be restored and aligned with the respective apertures 34may, for example, be defined by existing tooth structure or by thedental restoration formed using the facial mold body 12 and lingual moldbody 14.

Each of the apertures 34 has a suitable configuration (e.g., shapeand/or size) for introducing restorative material into a mold cavitydefined by an interior surface 42 of door 40 and the interior moldsurface 64 (shown in FIG. 4) to cover the portion of the surface of thetooth to be restored, where both interior surfaces 42, 64 are surfacesfacing the tooth or teeth to be restored. When door 40 is mated with arespective aperture 34, the surface 42 of the door 40 and the toothstructure of a patient may help shape the restorative material that isplaced in the mold cavity, e.g., in order to define the surface of thetooth to be restored.

In some embodiments, the shape of one or more of apertures 34 may bedesigned to substantially match the shape of the tooth and/or theportion of the tooth to be restored. For example, apertures 34 may besubstantially noncircular. In other examples, however, the shape of oneor more apertures 34 may be circular.

Apertures 34 may be sized to be larger than a tip of a dental capsule ora syringe tip that is used to introduce restorative dental material intothe mold cavity defined by mold bodies 12, 14. Apertures 34 may besufficiently large to allow placement and flow of restorative materialto cover the portion of the surface of the tooth being restored.Additionally, or alternatively, apertures 34 may be sufficiently largeto allow movement of the tip of the capsule or syringe tip withinaperture 34.

The facial mold body 12 may have individual doors 40 sized to closelyfit with corresponding apertures 34. Each door 40 may be attached to thefacial mold body 12 as illustrated with a hinge 48 and hinge pin 46 atone end, and an attachment mechanism 44 at the other end. The attachmentmechanism 44 in this case is a clip 44 which is designed to clip over orsnap onto an engagement surface 43 (shown in FIGS. 5 and 6) on thelingual mold body 14. As such, the hinge 48 and hinge pin 46 areadjacent the gingiva of the patient's teeth and the clip 44 andengagement surface 43 are adjacent the occlusal surfaces of thepatient's teeth or located proximate an incisal edge of a tooth or teethto be restored. This arrangement is convenient for the clip to snapunder the occlusal surfaces or incisal edge of the patient's teeth,spaced away from their tongue. However, in other embodiments notillustrated, their relative positions may be reversed, with the clip 44and engagement surface 43 adjacent the gingiva of the patient's teethand hinge 48 and hinge pin 46 adjacent the incisal or occlusal surfacesof the patient's teeth.

In the illustrated embodiment, the door body 40 and facial mold body 12are mechanically connected to each other by using a hinge 48 and hingepin. This configuration helps maintain proper alignment between the doorbody 40 and corresponding aperture 34 during use of custom tool 10.However, door body 40 and facial mold body 12 may be connected via asnap hinge, a living hinge, a barrel hinge, a pin joint hinge, or anyother suitable type of hinge. Door hinge 48 and hinge pin 46 may beformed separate from the door body 40 and/or facial mold body 12, ordoor hinge 48 and hinge pin 46 may be formed as an integral part of doorbody 40 and/or facial mold body 12.

The facial mold body 12 may include a first alignment member 52, whichassists in properly aligning the facial and lingual mold bodies 12, 14before interlocking them together. In the illustrated embodiment, thefirst alignment member 52 is a post that is sized to fit with the secondalignment member 54 in the lingual mold body 14, shown as a slot 55 inFIGS. 4-6.

The facial mold body 12 and lingual mold body 14 may be configured tocombine with at least one tooth of the patient to define a mold cavityencompassing at least a portion of desired tooth structure of the toothor teeth to be restored. For example, in the illustrated example, thefacial mold body 12 and lingual mold body 14 may combine with teeth ofthe patient to define a mold cavity encompassing at least a portion ofdesired tooth structure for each of the teeth with facial portionsaligning with apertures 34 a and 34 b. In some examples, the dentalrestoration may include a dental veneer restoration on the tooth orteeth to be restored, and the apertures 34 a and 34 b may allow apractitioner to have better control over the placement of restorativematerial in the mold cavity than a traditional mold. For example, theapertures 34, which align with a majority of a surface of a lingual orfacial surface of a tooth may allow a practitioner to have bettercontrol over the final appearance of that surface, including the finalsurface texture, shading, and layering of the restorative materials.

In the illustrated example, door body 40 includes a vent 50. The vent 50may be configured to allow excess restorative material to flow out of amold cavity, which may be removed prior to curing (e.g., with a scalarinstrument), providing for easier removal of flash. Alternatively, or inaddition, vent 50 may be configured to allow air to flow out of the moldcavity.

The facial mold body 12 may include a custom gingival surface 36 that isgenerally contoured to match the gingiva, but not engaging the gingiva.This allows excess restoration material to be cleanly removed. Thefacial mold body 12 may also include a facial rib 38 to provide overallstrength to the facial mold body.

Custom tool 10 may include a lingual mold body 14, which may also beconfigured to provide a customized fit with the at least one tooth ofthe patient. FIGS. 4, 5, and 6 illustrate views of one embodiment of thelingual mold body 14. Facial mold body 12 and lingual mold body 14 maybe configured to combine with the at least one tooth of the patient toform the mold cavity. For example, facial mold body 12 and lingual moldbody 14 may be configured to mate with one another and/or to be attachedto the at least one tooth to form the mold cavity. In some examples,lingual mold body 14 is separable from and engageable with the facialmold body 12, while maintaining the integrity of the respective moldbodies, through use of their engagement portions 18, 19.

In the example shown in FIGS. 4-6, the lingual mold body 14 includes arestorative portion 17 and an engagement portion 19. A practitioner usesthe restorative portion 17 of the custom tool to restore at least onetooth in the mouth of the patient. In the illustrated embodiment, thereare two engagement portions 19 a, 19 b positioned at opposite ends ofthe restorative portion 17, which is located between the engagementportions 19 a, 19 b. This is ideal, but not necessary. For example, thelingual mold body 14 could include just one engagement portion 19positioned adjacent the restorative portion 17. In tools having twoengagement portions 19 a, 19 b, this provides two points of interlockbetween the facial and lingual mold bodies 12, 14, respectively.

Lingual mold body 14 includes first engagement portion 19 a and secondengagement portions 19 b. The engagement portions 19 a, 19 b of thelingual mold body 14 are structured to engage with or interlock with theengagement portions 18 a, 18 b on the facial mold body 12, as explainedin more detail below in reference to FIGS. 7, 8, and 9.

The first engagement portion 19 a and second engagement portion 19 bboth extend away from the restorative portion. In the illustratedembodiment, the engagement portions 19 extend at a generally right anglerelative to the restorative portion 17. When compared to the patient'smouth, which includes an occlusal plane illustrated as reference lineA-A (shown in FIG. 6), the engagement portions 19 extend generallyperpendicular to the occlusal plane.

As illustrated in FIG. 6, engagement portions 19 of the lingual moldbody 14 may include a variety of engagement surfaces configured to mateappropriately with the engagement surfaces 24, 26, 28 on the facial moldbody 12. Engagement portions 19 a, 19 b of the lingual mold body 14 mayinclude an indentation 30 a, 30 b respectively or some other mechanismknown in the art for interlocking with the facial mold body 12. In theillustrated embodiment, indentation 30 includes a first engagementsurface 31, a second engagement surface 32, and a third engagementsurface 33. Indentations 30 a, 30 b are sized and shaped to interlock orsnap fit with the protrusions 20 a, 20 b in the facial mold body 12.Various structures known in the art may be substituted for theindentations 30 and protrusion 20, so long as they assist in securelyinterlocking the lingual mold body 14 to the facial mold body 12.

In the illustrated embodiment, the restorative portion 17 is sized andshaped to mate with the anterior teeth of a patient. The engagementportions 19 are sized and shaped to be adjacent the posterior teeth.However, in other embodiments (not illustrated), an engagement portion19 could be adjacent the anterior teeth and the restorative portion 17mate with the posterior teeth.

The lingual mold body 14 includes a plurality of an engagement surfaces43 adjacent the occlusal surfaces of the patient's teeth or locatedproximate to an incisal edge of a tooth or teeth to be restored. Thisarrangement is convenient for the clip 44 (shown in FIGS. 1-3) to snapunder the occlusal surfaces or incisal edge of the patient's teeth,spaced away from their tongue. However, in other embodiments notillustrated, the engagement surface 43 may instead be adjacent thegingiva of the patient's teeth, with the clip 44 likewise being in asimilar position.

The lingual body 14 includes mold surfaces 64 sized to createappropriate mold cavity or cavities with the inner surface 42 of thedoor 40 (shown in FIGS. 1-3) and/or in combination with the toothstructure of a patient to help shape the restorative material that isplaced in the mold cavity or cavities in order to define the surface ofthe tooth or teeth to be restored.

The lingual mold body 14 may include a custom lingual rib 39 to provideadditional clamping or mating to the individual patient's mouth.

The lingual mold body 14 may include a second alignment member 54 sizedand shaped to fit with the first alignment member 52. In the illustratedembodiment, the second alignment member 54 may be mesial alignmentreceptor. Specifically, the second alignment member may be a slot 55sized to receive the post 52 on the facial mold body 12. FIGS. 8a, 8b ,9 and 10 are useful for illustrating how the facial mold body 12 andlingual mold body 14 are assembled together and around the teeth of apatient to form a custom tool 10. One of the major benefits of thisdesign is that once assembled, movement between the facial mold body andthe lingual mold body is restricted in multiple directions and multiplerotations. As a result, practitioners are able to create more accuraterestorations for their patients.

With FIGS. 8a and 8b as a point of reference, a practitioner may firstplace the lingual mold body 14 behind the patient's teeth, with thesecond alignment member 54 centered adjacent the occlusal surfaces ofthe patient's teeth. Then, the practitioner may place the facial moldbody 12 over the front of the teeth and align the first alignment member52, the post, to fit into the second alignment member 54, the hole.However, in other embodiments, mold bodies 12, 14 could include indiciaor alignment features (e.g., visual indicators, other forms ofmechanical mating features, keyholes, notches, and the like) to help apractitioner properly align and easily engage facial mold body 12 andlingual mold body 14 with one another.

The facial and lingual mold bodies 12, 14 are preferably made offlexible materials to bend them at certain radiuses to successfullyinterlock them together, as illustrated in FIGS. 8a and 8b . Apractioner will interlock the mold bodies 12, 14 together by placing theprotrusions 20 a, 20 b into the corresponding indentations 30 a, 30 b.The release tabs 22 a, 22 b may optionally be used to help fitprotrusions 20 a, 20 b into the indentations 30 a, 30 b. Custom toolscan be made from the full range of 3D printed materials, moldedpolymeric material or CAD/CAM shaped polymeric materials having certaindesired strength, flexibility, translucency, or color. For example, themold material can be polymeric material that may be transparent,translucent, or opaque. In some embodiments, clear or substantiallytransparent polymeric material that may include, for example, one ormore of amorphous thermoplastic polymers, semi-crystalline thermoplasticpolymers, transparent thermoplastic polymers, and thermoset polymers.Thermoplastics can be chosen from polycarbonate, thermoplasticpolyurethane, acrylic, polysulfone, polyprolylene,polypropylene/ethylene copolymer, cyclic olefin polymer/copolymer,poly-4-methyl-1-pentene or polyester/polycarbonate copolymer, styrenicpolymeric materials, polyamide, polymethylpentene, polyetheretherketoneand combinations thereof. In another embodiment, the mold may be chosenfrom clear or substantially transparent semi-crystalline thermoplastic,crystalline thermoplastics and composites, such as polyamide,polyethylene terephthalate. polybutylene terephthalate,polyester/polycarbonate copolymer, polyolefin, cyclic olefin polymer,styrenic copolymer, polyetherimide, polyetheretherketone,polyethersulfone, polytrimethylene terephthalate, and mixtures andcombinations thereof. In some embodiments, the mold is a polymericmaterial chosen from polyethylene terephthalate, polyethyleneterephthalate glycol, poly cyclohexylenedimethylene terephthalateglycol, and mixtures and combinations thereof. In additional embodimentsthermoset polymers include acrylics, urethanes, esters, silicones,thiolenes, epoxies, olefin metathesis and combinations thereof.

The custom tool 10 is designed to ensure a relatively tight fit betweenthe mold bodies 12, 14 to assure an accurate and precisely shapedrestoration while helping reduce or eliminate the flash that occursalong the edge where to the two mate together. Any flash that does occurmay be very thin along the incisal edge and may be easily removed with adental instrument. By providing a relatively tight fit along the incisaledge or another edge of mold bodies 12,14, this may help excessrestorative material preferentially flow toward vent 50 where flash maybe relatively easily seen and removed during finishing of therestoration.

FIG. 8b is convenient for describing the clamping force that can begenerated between the facial mold body 12 and the lingual mold body 14.The facial mold body 12 has a certain arch length (C, and the lingualmold body 14 has a certain arch length (D). When the custom tool 10 ismade, the geometry of the facial and/or lingual mold bodies 12, 14 isaltered. For instance, the arch length C of the facial mold body 12 maybe shortened, while the arch length D of the lingual mold body ismaintained, and this configuration creates a clamping force between thetwo mold bodes 12, 14 when they are assembled. In addition, the moldbodies 12, 14 are sufficiently strong so as not to break or buckle, andthe protrusion 20 and the indentation 30 can be interlocked withoutcreating undue pressure in the mouth of the patient. Clamping forces canalso be generated by slightly reducing the radius of curvature of thefacial mold body 12, while maintaining the radius of curvature of thelingual mold body 14. Angle θ illustrates the latching surface relativeto the arch tangent.

The degree of clamping force between the facial mold body 12 and thelingual mold body 14 should be tailored to balance the security of theinstalled tool 10 around the patient's teeth and sealing it against thegingival tissues with ease of installation into and removal from thepatient's mouth. The degree of clamping force can be increased byincreasing the stiffness of the mold bodies 12, 14 via materials,geometry the amount of shortening of the facial mold body 12, and/orreduction of the radius of curvature of the facial mold body 12.Modifications to the mold bodies 12, 14 can be applied across the moldbodies, for instance by applying an appropriate shrinkage factor, orthey can be applied locally to various regions of the mold bodies and/orlatching mechanism between the two. Latch securement and ease ofengagement and removal can be tailored by adjusting the latching angle,length of the latching surfaces (engagement surface) 31 32, 33 andtopography of the surfaces 24, 26, 28 to obtain the best balance ofperformance. Tools such as finite element modeling can be used topredict the appropriate parameters for a given custom tool based on testresults of previously tested cases. Machine learning can be applied toimprove prediction capability over time, including feedback on clinicalperformance from practitioners. Digital design and manufacturing, suchas 3D printing or CNC machining, is particularly helpful in creatingcustom tool molds with active clamping forces.

FIG. 10 illustrates the custom dental restorative tool 10 clampedappropriately around the patient's teeth 72 in the mouth 70 of thepatient. The first engagement portions 18 a, 19 a of the facial andlingual mold bodies 12, 14 are interlocked together within the mouth,offset from the occlusal surfaces of the premolars and extending thedirection of the patient's tongue (not shown). Similarly, the secondengagement portions 18 b, 19 b of the facial and lingual mold bodies 12,14 are interlocked. In the illustrated embodiment, the patient is havingfive teeth restored.

FIGS. 11a-11d are convenient for illustrating the method steps for usingthe custom tool 10 of the present invention after the custom tool isproperly applied in the patient's mouth 70. FIG. 11a illustrates some ofthe doors 40 opened to allow access to the teeth to be restored. FIG.11b illustrates restorative material 80 applied to the teeth to berestored. FIGS. 11c illustrates curing of the restorative material 80within the custom tool 10. FIG. 11d illustrates the teeth 72 of thepatient's mouth 70 restored.

In some examples, apertures 34 of tool 10 may allow the practitioner toapply the restorative material 80 directly to the tooth to be restored.However, in other examples, the practitioner may apply the restorativematerial 80 to the tooth to be restored or to mold body 12, 14 beforeapplying mold bodies 12, 14 over the teeth 72 of the patient. Thepractitioner may fill the mold cavity defined by mold bodies 12, 14 andthe teeth around which the mold bodies 12, 14 are positioned withrestorative material 80 by introducing the restorative material 80through one or more of apertures 34 and into the mold cavity (FIG. 11b). In some examples, the practitioner may use various tools to place therestorative material into the mold cavity. In some examples, restorativematerial 80 may be placed in the mold cavity through multiple apertures34. One preferable dental restorative material is Filtek™ SupremeUniversal™, commercially available from 3M Company based in St. Paul,Minn. After at least some restorative material 80 is introduced into themold cavity, the practitioner may then close the door bodies 40 withinthe corresponding apertures 34 (FIG. 11c ). The inner surfaces 42 ofdoor bodies 40 and the mold surfaces 64 may be used to shape one or morelayers of restorative material 80 on the facial or lingual surface ofthe tooth 72, to compress restorative material 80 within the moldcavity, or any combination thereof.

In some examples, the practitioner may cure the restorative material 80,while the door bodies 40 are closed into the apertures 34 of the facialmold body 12. For example, if the restorative material is light curable,the practitioner may expose the restorative material to the curing light(e.g., a blue light) through one or both of the mold bodies 12, 14,which may be formed of a material transparent to the curing light. Thepractitioner may remove the facial mold body 12 and the lingual moldbody 14 from the teeth 72, which now have restored structure defined bythe restorative material (FIG. 11d ). Removing the mold bodies 12, 14from the mouth 70 may include separating the facial mold body 12 fromthe lingual mold body 14, which may include, for example, disengagingone or more of the first engagement portions 18 a, 19 a of the moldbodies 12, 14 from the second engagement portions 19 a, 19 b of the moldbodies 12, 14. In some example, the one or more of the door bodies 40may leave “witness marks” on the lingual or facial surface of the tooth,but such marks may be relatively easily removable because they arerelatively thin. In some examples, the practitioner may finish theteeth, which now include restored dental structure defined by therestorative material, such as by polishing, to remove flash or otherundesired surface imperfections.

In some examples, the practitioner may place a release film on at leasta portion of a surface 42 of the door 40 before placing the door 40within its respective aperture 34. The release film may reduce thelikelihood of trapping air within the mold cavity during stamping of therestorative material 80 with the door and/or may facilitate release ofrestorative material 40 from the surface 42 of the door 40.

In addition to, or instead of, the release film, in some examples, thedevice manufacturer or practitioner may apply a coating on at least aportion of a surface 42 of the door 40 and/or the door body beforeplacing the door 40 within the respective aperture 34. The coating mayreduce the likelihood of trapping air within the mold cavity duringstamping of the restorative material with the door and/or may facilitaterelease of restorative material from the surface of the door. Releasecoatings may also be applied to any of the mold components during themanufacturing process.

The introduction of the restorative material 80 into mold cavity mayhave enough force to separate parts of mold bodies 12, 14 from eachother, thereby providing less of an engagement between facial mold body12 and lingual mold body 14 and/or less of a customized fit with one ormore teeth. However, the engagement portions 18, 19 help mold bodies 12,14 self-align with each other and stay firmly fixed relatively to eachother.

FIGS. 12-14 illustrate another embodiment of custom tool 110 of thepresent invention. Custom tool 110 is configured the same of custom tool10 described above in detail relative to FIGS. 1-11, however custom tool110 has at least one door 140 covering two apertures 142.

FIGS. 12 and 13 illustrate an embodiment of a facial mold body 112 ofthe custom tool 110 of the present invention. FIG. 13 illustrates a backview of the facial mold body 112. FIG. 14 illustrates an embodiment of alingual portion 114 of the custom tool 110 of the present invention incombination with the facial mold body 112, showing how the two bodiesfit together to form a complete a custom tool 110 for forming apatient-specific dental restoration.

Like the example facial mold body 12 shown in FIG. 1, the facial moldbody 112 includes a restorative portion 116 and an engagement portion118. However, there are two restorative portions 116 used to restoreteeth on either side of the mesial incisors. In the illustratedembodiment, there are two engagement portions 118 a, 118 b positioned ateither ends restorative portions 116. The same as custom tool 10, customtool 110 has first engagement portions 118 a, 119 a, and secondengagement portions 118 b, 119 b, and this provides two points ofinterlock between the facial and lingual mold bodies 112, 114,respectively.

The first engagement portion 118 a and second engagement portion 118 bboth extend away from the restorative portion. In the illustratedembodiment, the engagement portions 118 extend at a generally rightangle relative to the restorative portion. When compared to thepatient's mouth, which includes an occlusal plane B-B established by theincisal and occlusal surfaces of all the teeth in the upper and lowerarch, the engagement portions 118 extend generally perpendicular to theocclusal plane.

As illustrated in FIG. 13, engagement portions 118 of the facial moldbody 112 may include a variety of engagement surfaces configured to mateappropriately with the engagement surfaces on a lingual mold body 114.Engagement portions 118 a, 118 b of the facial mold body 112 may includea protrusion 120 a, 120 b respectively or some other mechanism known inthe art for interlocking with the lingual mold body 114. In theillustrated embodiment, protrusion 120 includes a first engagementsurface 124, a second engagement surface 126, and a third engagementsurface 128, as discussed above. Protrusions 120 a, 120 b are sized andshaped to interlock or snap fit with the indentations 130 a, 130 b inthe lingual mold body 114. Various structures known in the art may besubstituted for the protrusion 120 and indentations 130, so long as theyassist in securely interlocking the facial mold body 112 to the lingualmold body 114.

The engagement portions 118 a, 118 b of the facial mold body 112 arestructured to engage with or interlock with the engagement portions onthe lingual mold body 114 explained in more detail above in reference tofacial mold body 12 and lingual mold body 14 in FIGS. 7, 8, and 9.

In the illustrated embodiment, the restorative mold body 116 is sizedand shaped to mate with the anterior teeth of a patient. The engagementportions 118 are adjacent the posterior teeth. However, in otherembodiments (not illustrated), an engagement portion 118 could beadjacent the anterior teeth and the restorative portions 116 could besized and shaped to mate with the posterior teeth.

In the example shown in FIGS. 12 and 13, the facial body 112 includesone or more apertures 134, which may each be configured to align with aportion of a facial surface of a respective tooth of the patient to berestored. In some examples, the portion is a majority of the facialsurface of the tooth to be restored. In this embodiment shown in FIG. 12to-14, there are dual doors 140 covering two apertures 134. As such, thedoor 140 is configured to align with a portion comprising a majority ofthe facial surfaces of two teeth and two apertures 134 are be configuredto align with a portion comprising a majority of a facial surface of twoteeth. The surface of the teeth to be restored and aligned with therespective apertures 134 may, for example, be defined by existing teethstructure or by the dental restoration formed using the facial mold body112 and lingual mold body 114.

FIGS. 15 and 16 illustrate an embodiment of a facial mold body 212 ofthe custom tool 200 of the present invention. FIG. 17 illustrates anembodiment of a lingual portion 214 of the custom tool 200 of thepresent invention in combination with the facial mold body 212, showinghow the two bodies fit together to form a complete a custom tool 200 forforming a patient-specific dental restoration. The embodiments shown inFIGS. 15-17 are very similar to the embodiments shown in FIGS. 11-13,except the relative positions of the hinges 148 and doors 140 areswitched.

Like the example facial mold body 12 shown in FIG. 1, the facial moldbody 212 includes a restorative portion 216 and an engagement portion218. However, there are two restorative portions 216 used to restoreteeth on either side of the mesial incisors. In the illustratedembodiment, there are two engagement portions 218 a, 218 b positioned ateither ends restorative portions 216. The same as custom tool 10, customtool 200 has first engagement portions 218 a, 219 a, and secondengagement portions 218 b, 219 b, and this provides two points ofinterlock between the lingual and facial mold bodies 212, 214.

The first engagement portion 218 a and second engagement portion 218 bboth extend away from the restorative portion. In the illustratedembodiment, the engagement portions 218 extend at a generally rightangle relative to the restorative portion. When compared to thepatient's mouth, which includes an occlusal plane C established by theincisal and occlusal surfaces of all the teeth in the upper and lowerarch, the engagement portions 218 extend generally perpendicular to theocclusal plane.

Engagement portions 218 of the facial mold body 212 may include avariety of engagement surfaces configured to mate appropriately with theengagement surfaces on a lingual mold body 214. Engagement portions 218a, 218 b of the facial mold body 212 may include a protrusion 220 a, 220b respectively or some other mechanism known in the art for interlockingwith the lingual mold body 214. In the illustrated embodiment,protrusion 220 includes a first engagement surface 224. a secondengagement surface 226, and a third engagement surface 228. Protrusions220 a, 220 b are sized and shaped to interlock or snap fit with theindentations 230 a, 230 b in the lingual mold body 214. Variousstructures known in the art may be substituted for the protrusion 220and indentations 230, so long as they assist in securely interlockingthe facial mold body 212 to the lingual mold body 214.

The engagement portions 218 a, 218 b of the facial mold body 212 arestructured to engage with or interlock with the engagement portions onthe lingual mold body 214 explained in more detail above in reference tofacial mold body 12 and lingual mold body 14 in FIGS. 7, 8, and 9.

In the illustrated embodiment, the restorative mold body 216 is sizedand shaped to mate with the anterior teeth of a patient. The engagementportions 218 are adjacent the posterior teeth. However, in otherembodiments (not illustrated), an engagement portion 218 could beadjacent the anterior teeth and the restorative portions 216 could besized and shaped to mate with the posterior teeth. FIGS. 18a-18cillustrate additional embodiments of the custom tool of the presentdisclosure.

In the example shown in FIG. 16, the facial body 212 includes one ormore apertures 234, which may each be configured to align with a portionof a facial surface of a respective tooth of the patient to be restored.In some examples, the portion is a majority of the facial surface of thetooth to be restored. In this embodiment shown in FIG. 15-17, there aredual doors 240 covering two apertures 234. As such, the door 240 isconfigured to align with a portion comprising a majority of the facialsurfaces of two teeth and two aperture 234 are be configured to alignwith a portion comprising a majority of a facial surface of two teeth.The surface of the teeth to be restored and aligned with the respectiveapertures 234 may, for example, be defined by existing teeth structureor by the dental restoration formed using the facial mold body 212 andlingual mold body 214.

FIGS. 18a-18c illustrate additional embodiments of custom tools 300,302, 304 of the present invention, where the hinges 144 pivot adjacentthe patient's gingiva. The embodiments shown in FIGS. 18a-18c are verysimilar to the embodiments shown in the other Figures, except they areengaged with different portions of the patient's mouth.

FIG. 18a illustrates an embodiment of a custom tool 300, where thecustom tool 300 engages with a portion of the arch of the patient'smouth 70, specifically the portion of the patient's arch extendingbetween a molar tooth and an incisor tooth. The engagement portions 119of the lingual mold body 114 are in combination with the engagementportions 118 of the facial mold body 112 to form a complete the customtool 300 for forming a patient-specific dental restoration. Engagementportion 119 a combines with protrusion 120 a of engagement portion 118 ato interlock adjacent one of the patient's incisor teeth. Engagementportion 119 b combines with protrusion 120 b of engagement portion 118 bto interlock adjacent one of the patient's molar teeth. The release tabs122 a, 122 b may optionally be used to help fit protrusions 120 a, 120 binto the indentations 130 a, 130 b. The lingual mold body 114 mayinclude a custom lingual rib 139 to provide additional clamping ormating to the individual patient's mouth.

FIG. 18b illustrates an embodiment of a custom tool 302, where thecustom tool 302 engages with the full arch of the patient's mouth 70,specifically the portion of the patient's arch extending between onemolar tooth and another molar tooth. The engagement portions 119 of thelingual mold body 114 are in combination with the engagement portions118 of the facial mold body 112 to form a complete the custom tool 302for forming a patient-specific dental restoration. Engagement portion119 a combines with protrusion 120 a of engagement portion 118 a tointerlock adjacent one of the patient's incisor teeth. Engagementportion 119 b combines with protrusion 120 b of engagement portion 118 bto interlock adjacent one of the patient's molar teeth. The release tabs122 a, 122 b may optionally be used to help fit protrusions 120 a, 120 binto the indentations 130 a, 130 b. The lingual mold body 114 mayinclude a custom lingual rib 139 to provide additional clamping ormating to the individual patient's mouth.

FIG. 18c illustrates an embodiment of a custom tool 304, where thecustom tool 304 engages with a portion of the arch of the patient'smouth 70, specifically the portion of the patient's arch extendingbetween a molar tooth and a premolar tooth. The engagement portions 119of the lingual mold body 114 are in combination with the engagementportions 118 of the facial mold body 112 to form a complete the customtool 300 for forming a patient-specific dental restoration. Engagementportion 119 a combines with protrusion 120 a of engagement portion 118 ato interlock adjacent one of the patient's incisor teeth. Engagementportion 119 b combines with protrusion 120 b of engagement portion 188 bto interlock adjacent one of the patient's molar teeth. The release tabs122 a, 122 b may optionally be used to help fit protrusions 120 a, 120 binto the indentations 130 a, 130 b. The lingual mold body 114 mayinclude a custom lingual rib 139 to provide additional clamping ormating to the individual patient's mouth.

FIG. 19 illustrates an embodiment of a custom tool 500 for forming adental restoration, where the custom tool 500 includes injection ports520 and two different embodiments of engagement portions 519 a, and 519b. The custom tool 520 includes injection ports 520 for delivery ofrestorative dental material into the mold cavities formed between thefacial mold body 512 and the lingual mold body 514. In this embodiment,the ports 520 are formed when the facial mold body 512 and lingual moldbody 514 fit together to form a complete the custom tool 500 for forminga patient-specific dental restoration. Optionally, the custom tool 500may include plugs (not shown) for positioning in the ports 520 followingthe injection of the restorative dental material into the mold cavities.

The facial mold body 512 may include first alignment members 552 a, 552b and the lingual mold body 514 may include second alignment members 554a, 554 b, all of which assist in properly aligning the facial andlingual mold bodies 512, 514 before interlocking them together. Thefirst alignment member 552 a interlocks with second alignment member 554a. The first alignment member 552 b interlocks with second alignmentmember 554 b. In this embodiment, the injection ports 520 are positionedbetween the alignment members 552 a, 554 a, 552 b, 554 b respectively,however this is not necessary.

The lingual mold body 514 may include engagement portion 519 a or 519 b,as illustrated. However, other engagement portions may be used asdiscussed above.

The custom molds of the present invention are advantageous of those ofthe prior art. As one example U.S. Pat. No. 8,366,445 (Vuillemot) showsin FIGS. 4- 5 alignment features to register the buccal and lingual moldportions. The alignment features are placed on the interfacial surfacebetween the buccal and lingual molds. They may be toleranced to providesome frictional resistance to secure the assembled molds. This has theseveral disadvantages over the spaced part engaging portions thatinterlocks. For example, the retentive features as shown in Vuillemotcomplicate the seating and curing of the mold. To create space for theretentive features, the mold interface area must be expanding, resultingin a more bulky design. If frictional forces are used to secure themold, then these same frictional forces must be overcome to seat themold and it is difficult to know when the mold halves are completelyseated. Molds that are not completely seated will lead to flash as thecomposite flows into the gap during use. The retentive features on themating surface result in bonding of the composite to the mold during thecuring process and make removal of the molds extremely difficult.

In contrast, the interlocking engaging portions of the presentinvention, are not placed along the interface, rather they areseparately located away from the interfacial surface. This providesseveral advantages. The interface between the lingual and facial moldsis not expanded or complicated by fine alignment features, rather it issmooth, easy to seat closed, and easy to verify that it is seated. Thereis a smooth interfacial surface to minimize retention forces of anyflash cured at the interface. The present latching mechanism(interlocking engaging portion) is physically separated from the areaswhere flash may be expressed during filling. The present latchingmechanism (interlocking engaging portion) is separately activated fromthe seating and releasing of the facial and lingual molds byeasy-to-grasp tabs. Lastly, the present latching mechanism (interlockingengaging portion) can be configured to provide a designed interferencebetween facial and lingual molds such that a residual seating pressureexists when the engagement portions are interlocked, even when thefacial and lingual molds are closed. This seating pressure helps to keepthe custom tool remain securely shut even under the pressure ofcomposite filling.

Custom tools as described herein may be formed based on a digital modelof the teeth and mouth of an individual patient, which can be producedfrom an intra-oral 3D scan, such as an intraoral scanner. In oneparticular example, the custom tools may be digitally designed using CADsoftware, such as solid modeling software based on the digital model ofthe planned restored dentition. Custom tool was designed to fit over thetooth or teeth to be restored teeth (the restorative portion) and aportion of the neighboring teeth (the engagement portions).Subsequently, the tooth structure model of the restored teeth may bedigitally subtracted from a mold block to create a tool. Alternatively,an inverse of the tooth structure may be inverted within software todefine the mold block. Engagement portions may be located in regionswhich correspond to regions of the teeth where they will extend from.

Within the digital model, the mold block design may be segmented intotwo sections (facial mold body and lingual mold body) to facilitateeventual assembly of the tool components on the teeth, with specificgeometric interferences selected related to the arch lengths to providedesired the clamping forces, as discussed above. Within the digitalmodel, engagement portions with certain interlocking geometries aredesigned, selecting overall heights of the engagement portions basedwhere the engagement portions are placed within the patient's mouth, asdiscussed in more detail above.

Exemplary Embodiments

Embodiment 1 is a custom tool for forming a dental restoration in amouth of a patient, the custom tool comprising: a facial mold body for apatient-specific, customized fit with the facial side of at least onetooth of the patient, wherein the facial mold body includes arestorative portion and a first engagement portion extending away fromthe restorative portion; a lingual mold body for a patient-specific,customized fit with the lingual side of the tooth of the patient,wherein the lingual mold body includes a restorative portion and a firstengagement portion extending away from the restorative portion; whereinthe first engagement portion of the facial mold body interlocks with thefirst engagement portion of the lingual mold body; and wherein thefacial mold body and lingual mold body are configured to combine withthe tooth of the patient to form a mold cavity encompassing missingtooth structure of at least one tooth to be restored.

Embodiment 2 is the custom tool of Embodiment 1, wherein the facial moldbody includes a second engagement portion extending away from therestorative portion, and wherein the lingual mold body includes a secondengagement portion extending away from the restorative portion; andwherein the second portion of the facial mold body interlocks with thesecond portion of the lingual mold body.

Embodiment 3 is the custom tool of Embodiments 1-2, wherein the mouth ofthe patient includes an occlusal plane, and wherein the first engagementportion of the facial mold body and the first engagement portion of thelingual mold body extend generally perpendicular to the occlusal plane.

Embodiment 4 is the custom tool of Embodiments 1-2, wherein the firstengagement portions are proximate the anterior teeth of the patient andthe second engagement portions are proximate the posterior teeth of thepatient, and the restoration portions of the facial mold body andlingual mold body mate with either the anterior or posterior teeth.

Embodiment 5 is the custom tool of Embodiments 1-2, wherein the mouth ofthe patient includes an occlusal plane, wherein the first engagementportion and second engagement portion of the facial mold body extendgenerally perpendicular to the occlusal plane, and wherein the firstengagement portion and second engagement portion of the lingual moldbody extend generally perpendicular to the occlusal plane.

Embodiment 6 is the custom tool of any of the preceding Embodiments,further including a first mesial alignment member on the facial moldbody and a second mesial alignment member on the lingual mold body.

Embodiment 7 is the custom tool of any of the preceding Embodiments,wherein the restorative portions of the facial mold body and lingualmold body mate with anterior teeth of the patient, and wherein theengagement portions are proximate to posterior teeth of the patient.

Embodiment 8 is the custom tool of any of the preceding Embodiments,wherein the restorative portions of the facial mold body and lingualmold body mate with posterior teeth of the patient, and wherein theengagement portions are proximate to anterior teeth of the patient.

Embodiment 9 is the custom tool of any of the preceding Embodiments,wherein the first engagement portion of the facial mold body includes aprotrusion and wherein the first engagement portion of the lingual moldbody includes an indentation, wherein the protrusion of the facial moldbody interlocks with the indentation of the lingual mold body adjacentto an occlusal plane of a patient's mouth.

Embodiment 10 is the custom tool of any of the preceding Embodiments,wherein the first engagement portion of the lingual mold body includes aprotrusion and wherein the first engagement portion of the facial moldbody includes an indentation, wherein the protrusion of the lingual moldbody interlocks with the indentation of the facial mold body adjacent toan occlusal surface of a patient's tooth.

Embodiment 11 is the custom tool of any of the preceding Embodiments,wherein the facial mold body has a customized fit with the facial sideof multiple teeth of the patient and the lingual mold body has acustomized fit with the lingual side of multiple teeth of the patient.

Embodiment 12 is the custom tool of any of the preceding Embodiments,wherein the mouth of the patient includes an occlusal plane, and whereinfirst engagement portion of the facial mold body and the firstengagement portion of the lingual mold body extend in a facial directionrelative to the occlusal plane.

Embodiment 13 is the custom tool of any of the preceding Embodiments,wherein the mouth of the patient includes an occlusal plane, and whereinfirst engagement portion of the facial mold body and the firstengagement portion of the lingual mold body extend in a lingualdirection relative to the occlusal plane.

Embodiment 14 is a custom tool for forming a dental restoration in amouth of a patient, the mouth of the patient including an occlusalplane, the custom tool comprising: a facial mold body for apatient-specific, customized fit with the facial side of at least onetooth of the patient, wherein the facial mold body includes arestorative portion a first engagement portion extending away from therestorative portion and generally perpendicular to the occlusal plane,and a second engagement portion extending away from the restorativeportion and generally perpendicular to the occlusal plane; a lingualmold body for a patient-specific, customized fit with the lingual sideof the tooth of the patient, wherein the lingual mold body includes arestorative portion, a first engagement portion extending away from therestorative portion, and a second engagement portion extending away fromthe restorative portion; a first mesial alignment member on the facialmold body and a second mesial alignment member on the lingual mold body;wherein the first engagement portion of the facial mold body interlockswith the first engagement portion of the lingual mold body and whereinthe second engagement portion of the lingual mold body interlocks withthe second engagement portion of the lingual mold body; wherein thefirst mesial alignment member interlocks with the second mesialalignment member; and wherein the facial mold body and lingual mold bodyare configured to combine with the tooth of the patient to form a moldcavity encompassing missing tooth structure of at least one tooth to berestored.

Embodiment 15 is a custom tool used for dental treatment, the customtool comprising: a facial body for a patient-specific, customized fitwith the facial side of at least one tooth of the patient, wherein thefacial mold body includes a tooth contacting portion and a firstengagement portion extending away from the tooth contacting portion; alingual mold body for a patient-specific, customized fit with thelingual side of the tooth of the patient, wherein the lingual mold bodyincludes a tooth contacting portion and a first engagement portionextending away from the tooth contacting portion; wherein the firstengagement portion of the facial mold body interlocks with the firstengagement portion of the lingual mold body; and wherein the interlockportions are configured to provide a clamping force between the facialbody and lingual body.

Embodiment 16 is a method of forming a dental restoration, the methodcomprising: positioning a patient-specific a facial mold body over atleast one tooth to be restored of a patient, wherein the facial moldbody has a customized fit with the facial side of at least one tooth ofthe patient, wherein the facial mold body includes a restorative portionand a first engagement portion extending away from the restorativeportion; positioning a patient-specific lingual mold body over the leastone tooth to be restored, wherein the lingual mold body has customizedfit with the lingual side of the tooth of the patient, wherein thelingual mold body includes a restorative portion and a first engagementportion extending away from the restorative portion; interlocking thefirst engagement portion of the facial mold body with the firstengagement portion of the lingual mold body to combine with the tooth ofthe patient to form a mold cavity encompassing missing tooth structureof at least one tooth to be restored; introducing restorative materialinto the mold cavity; curing the restorative material; and removing thefacial and lingual mold bodies from the at least one tooth.

Embodiment 17 is the method of Embodiment 16, wherein the introducingstep occurs before the interlocking step.

Embodiment 18 is the method of forming a dental restoration, the methodcomprising: applying dental restorative material onto the surface overat least one tooth to be restored of a patient; positioning apatient-specific a facial mold body over the at least one tooth to berestored and the dental restorative material, wherein the facial moldbody has a customized fit with the facial side of at least one tooth ofthe patient, wherein the facial mold body includes a restorative portionand a first engagement portion extending away from the restorativeportion; positioning a patient-specific lingual mold body over the atleast one tooth to be restored and the restorative material, wherein thelingual mold body has customized fit with the lingual side of the toothof the patient, wherein the lingual mold body includes a restorativeportion and a first engagement portion extending away from therestorative portion; interlocking the first engagement portion of thefacial mold body with the first engagement portion of the lingual moldbody to combine with the tooth of the patient to form a mold cavityencompassing missing tooth structure of at least one tooth to berestored, wherein the dental restorative material is contained withinthe mold cavity;

curing the restorative material; and removing the facial and lingualmold bodies from the at least one tooth.

Embodiment 19 is a method of designing a custom tool for forming adental restoration of a tooth, the method comprising: receiving, by oneor more processors, three-dimensional scan data of a supragingival toothstructure of a patient; designing, by the one or more processors, acustom tool for forming the dental restoration of the tooth based on thethree-dimensional scan data of the supragingival tooth structure of thepatient, and the desired tooth structure of the at least one tooth to berestored of the patient, wherein the tool comprises a facial mold bodyfor a patient-specific, customized fit with the facial side of at leastone tooth of the patient, wherein the facial mold body includes arestorative portion and a first engagement portion extending away fromthe restorative portion; a lingual mold body for a patient-specific,customized fit with the lingual side of the tooth of the patient,wherein the lingual mold body includes a restorative portion and a firstengagement portion extending away from the restorative portion; whereinthe first engagement portion of the facial mold body interlocks with thefirst engagement portion of the lingual mold body; and wherein thefacial mold body and lingual mold body are configured to combine withthe tooth of the patient to form a mold cavity encompassing missingtooth structure of at least one tooth to be restored.

Embodiment 20 is the method of Embodiment 19, wherein the facial andlingual mold bodies are manufactured by three-dimensional printing.

Embodiment 21 is the method of Embodiments 19-20, wherein the facial andlingual mold bodies are manufactured by CAD/CAM milling processes.

Embodiment 22 is the method of Embodiments 19-21, further includingreceiving, by one or more processors, information relating to asubgingival tooth structure of the patient.

Embodiment 23 is a custom tool used for dental treatment, the customtool comprising: a facial body for a patient-specific, customized fitwith the facial side of at least one tooth of the patient, wherein thefacial mold body includes a tooth contacting portion and a firstengagement portion extending away from the tooth contacting portion; alingual mold body for a patient-specific, customized fit with thelingual side of the tooth of the patient, wherein the lingual mold bodyincludes a tooth contacting portion and a first engagement portionextending away from the tooth contacting portion; wherein the firstengagement portion of the facial mold body interlocks with the firstengagement portion of the lingual mold body; and wherein there is adesigned interference between facial and lingual molds such that aresidual seating pressure exists when the engagement portions areinterlocked.

Embodiment 24 is custom tool of Embodiment 1, wherein the custom tool isconfigured to combine with a portion of the patient's dental archextending between a molar tooth and an incisor tooth.

Embodiment 25 is custom tool of Embodiment 1, wherein the custom tool isconfigured to combine with a portion of the patient's dental archextending between one molar tooth and another molar tooth.

Embodiment 26 is custom tool of Embodiment 1, wherein the custom tool isconfigured to combine with a portion of the patient's dental archextending between a molar tooth and a premolar tooth.

Embodiment 27 is custom tool of Embodiment 1, further including a port,wherein a dental restoration material may be injected into the moldcavity through the port.

1. A custom tool for forming a dental restoration in a mouth of apatient, the custom tool comprising: a facial mold body for apatient-specific, customized fit with the facial side of at least onetooth of the patient, wherein the facial mold body includes arestorative portion and a first engagement portion extending away fromthe restorative portion; a lingual mold body for a patient-specific,customized fit with the lingual side of the tooth of the patient,wherein the lingual mold body includes a restorative portion and a firstengagement portion extending away from the restorative portion; whereinthe first engagement portion of the facial mold body interlocks with thefirst engagement portion of the lingual mold body; and wherein thefacial mold body and lingual mold body are configured to combine withthe tooth of the patient to form a mold cavity encompassing missingtooth structure of at least one tooth to be restored.
 2. The custom toolof claim 1, wherein the facial mold body includes a second engagementportion extending away from the restorative portion, and wherein thelingual mold body includes a second engagement portion extending awayfrom the restorative portion; and wherein the second portion of thefacial mold body interlocks with the second portion of the lingual moldbody.
 3. The custom tool of claim 1, wherein the mouth of the patientincludes an occlusal plane, and wherein the first engagement portion ofthe facial mold body and the first engagement portion of the lingualmold body extend generally perpendicular to the occlusal plane.
 4. Thecustom tool of claim 2, wherein the first engagement portions areproximate the anterior teeth of the patient and the second engagementportions are proximate the posterior teeth of the patient, and therestoration portions of the facial mold body and lingual mold body matewith either the anterior or posterior teeth.
 5. The custom tool of claim1, further including a first mesial alignment member on the facial moldbody and a second mesial alignment member on the lingual mold body. 6.The custom tool of claim 1, wherein the restorative portions of thefacial mold body and lingual mold body mate with anterior teeth of thepatient, and wherein the engagement portions are proximate to posteriorteeth of the patient.
 7. The custom tool of claim 1, wherein therestorative portions of the facial mold body and lingual mold body matewith posterior teeth of the patient, and wherein the engagement portionsare proximate to anterior teeth of the patient.
 8. The custom tool ofclaim 1, wherein the first engagement portion of the facial mold bodyincludes a protrusion and wherein the first engagement portion of thelingual mold body includes an indentation, wherein the protrusion of thefacial mold body interlocks with the indentation of the lingual moldbody adjacent to an occlusal plane of a patient's mouth.
 9. The customtool of claim 1, wherein the first engagement portion of the lingualmold body includes a protrusion and wherein the first engagement portionof the facial mold body includes an indentation, wherein the protrusionof the lingual mold body interlocks with the indentation of the facialmold body adjacent to an occlusal surface of a patient's tooth.
 10. Thecustom tool of claim 1, wherein the facial mold body has a customizedfit with the facial side of multiple teeth of the patient and thelingual mold body has a customized fit with the lingual side of multipleteeth of the patient.
 11. The custom tool of claim 1, wherein the mouthof the patient includes an occlusal plane, and wherein first engagementportion of the facial mold body and the first engagement portion of thelingual mold body extend in a facial direction relative to the occlusalplane.
 12. The custom tool of claim 1, wherein the mouth of the patientincludes an occlusal plane, and wherein first engagement portion of thefacial mold body and the first engagement portion of the lingual moldbody extend in a lingual direction relative to the occlusal plane. 13.The custom tool of claim 1, wherein the custom tool is configured tocombine with a portion of the patient's dental arch extending between amolar tooth and an incisor tooth.
 14. The custom tool of claim 1,wherein the custom tool is configured to combine with a portion of thepatient's dental arch extending between one molar tooth and anothermolar tooth.
 15. The custom tool of claim 1, wherein the custom tool isconfigured to combine with a portion of the patient's dental archextending between a molar tooth and a premolar tooth.
 16. The customtool of claim 1, further including a port, wherein a dental restorationmaterial may be injected into the mold cavity through the port.
 17. Acustom tool for forming a dental restoration in a mouth of a patient,the mouth of the patient including an occlusal plane, the custom toolcomprising: a facial mold body for a patient-specific, customized fitwith the facial side of at least one tooth of the patient, wherein thefacial mold body includes a restorative portion a first engagementportion extending away from the restorative portion and generallyperpendicular to the occlusal plane, and a second engagement portionextending away from the restorative portion and generally perpendicularto the occlusal plane; a lingual mold body for a patient-specific,customized fit with the lingual side of the tooth of the patient,wherein the lingual mold body includes a restorative portion, a firstengagement portion extending away from the restorative portion, and asecond engagement portion extending away from the restorative portion; afirst mesial alignment member on the facial mold body and a secondmesial alignment member on the lingual mold body; wherein the firstengagement portion of the facial mold body interlocks with the firstengagement portion of the lingual mold body and wherein the secondengagement portion of the lingual mold body interlocks with the secondengagement portion of the lingual mold body; wherein the first mesialalignment member interlocks with the second mesial alignment member; andwherein the facial mold body and lingual mold body are configured tocombine with the tooth of the patient to form a mold cavity encompassingmissing tooth structure of at least one tooth to be restored.
 18. Acustom tool used for dental treatment, the custom tool comprising: afacial body for a patient-specific, customized fit with the facial sideof at least one tooth of the patient, wherein the facial mold bodyincludes a tooth contacting portion and a first engagement portionextending away from the tooth contacting portion; a lingual mold bodyfor a patient-specific, customized fit with the lingual side of thetooth of the patient, wherein the lingual mold body includes a toothcontacting portion and a first engagement portion extending away fromthe tooth contacting portion; wherein the first engagement portion ofthe facial mold body interlocks with the first engagement portion of thelingual mold body; and wherein the interlock portions are configured toprovide a clamping force between the facial body and lingual body. 19.(canceled)
 20. (canceled)
 21. (canceled)
 22. (canceled)
 23. (canceled)